System and method for patient temperature control

ABSTRACT

A patient temperature control system and method are provided for automated temperature control according to a programmed protocol. In one aspect, at least one programmed protocol may be established for each of a plurality of patient thermal therapy phases. In turn, the temperature of a thermal exchange medium may be controlled, based at least in part, upon the programmed protocol, during each of the phases. In another aspect, a plurality of programmed protocols may be established, wherein a selected one of the protocols (e.g. selected by a user at a user interface) may be utilized for automated temperature control during patient thermal therapy. The protocol(s) may include a target patient temperature and/or a set duration for one or more of the phase of thermal therapy. Further, the protocol(s) may be user-definable and modifiable during therapy. In a multi-phase configuration, automatic termination and initiation of successive phases may be selectively established by a user, based on target patient temperature data and/or set duration data on a phase-specific basis.

RELATED APPLICATIONS

This is a continuation of prior non-provisional U.S. patent application Ser. No. 15/431,489, filed Feb. 13, 2017, entitled “IMPROVED SYSTEM AND METHOD FOR PATIENT TEMPERATURE CONTROL”, which is a continuation of U.S. patent application Ser. No. 12/250,320, filed Oct. 13, 2008, entitled “IMPROVED SYSTEM AND METHOD FOR PATIENT TEMPERATURE CONTROL”, which claims benefit of provisional U.S. Patent Application No. 60/979,760, filed Oct. 12, 2007, entitled “SYSTEM AND METHOD FOR PATIENT TEMPERATURE CONTROL”, all of which foregoing applications are hereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to an improved system and method for patient temperature control via temperature control of a thermal exchange medium, including automated thermal control of a plurality of therapy phases based upon one or more programmed protocols.

BACKGROUND OF THE INVENTION

The therapeutic use of bodily cooling and heating systems, respectively, is ever-increasing. Hypothermia may occur for a variety of reasons, including exposure to cold environments, or complex surgical procedures.

During surgery, a patient typically experiences mild hypothermia as a result of the effect of general anesthesia on the body's thermoregulatory system and prolonged exposure of internal organs. Mild hypothermia in a surgical patient has been thought to prolong the time to extubation, contribute to coagulopathies, increase the chance of infection, and increase cardiac demand as a result of shivering. In such procedures, controlled patient warming may be of therapeutic benefit.

Hyperthermia may occur as a result of stroke, cardiac arrest and head trauma. In such cases it is now accepted that rapid cooling can yield significant therapeutic benefits. Specifically, research indicates that even though a stroke or cardiac arrest victim's brain cells may lose their ability to function, the cells do not necessarily die quickly. In fact, brain damage from a stroke or cardiac arrest may take hours to reach maximum effect. Neurological damage may be reduced and the stroke or cardiac arrest victims' outcome improved if a neuroprotectant therapy is applied within this time frame.

Similarly, elements in the genesis of a traumatic brain injury (e.g., resulting from falls, vehicular accidents and the like) are now understood to overlap with elements in the genesis of neurological damage in stroke victims. In particular, delayed secondary injury at the cellular level after the initial head trauma is now recognized as a measured contributing factor to the ultimate tissue loss that occurs after brain injury. Again, neurologic damage may be reduced if a neuroprotectant therapy is rapidly applied. Further, in this regard, studies have shown that treatment with mild hypothermia, defined as lowering core body temperature at 2-3 C° confers neuroprotection in stroke victims, and may hasten the neurologic recovery and improve outcomes when applied for 12-72 hours in cases of traumatic head injury. Again, to optimize such therapies, the neuro-protective therapy should be initiated as soon as possible after a stroke or traumatic head injury.

As reflected by the foregoing, significant therapeutic benefits may be realized through the use of bodily cooling and heating systems. In turn, systems which offer enhanced operational features are of particular interest as cooling/heating therapy modalities continue to evolve.

SUMMARY OF THE INVENTION

One objective of the present invention is to provide a patient temperature control system and method that facilitates enhanced reliability.

Another objective of the present invention is to provide an improved patient temperature control system and method that is user friendly.

Yet another objective of the present invention is to provide an improved patient temperature control system and method that facilitates the realization of enhanced efficiencies of medical care resources.

One or more of the noted objectives and additional advantages may be realized by the system and method of the present invention. The inventive system may be computer-based to include a user interface for receiving user control input and for providing corresponding output signals to a programmable control module.

In one aspect, the programmable control module may be provided to store control data and apply control logic in the generation of control signals in corresponding relation to a plurality of different patient temperature control phases (e.g. two or more). In this regard, a programmable multi-phase control module may be provided to facilitate the establishment of one or more protocols that each comprise parameter data for use in the control of patient temperature in each of the plurality of a patient temperature phases.

In another aspect, the programmable control module may be provided to facilitate the establishment of and to store two or more programmed protocols comprising control data, wherein the programmable control module may utilize a selected protocol and apply control logic in the generation of control signals in a patient thermal therapy procedure comprising one or more phases. In this regard, the user interface may be provided to facilitate the establishment of multiple programmed protocols, and to allow a user to a select a given one of the protocols for application in a given patient therapy. By way of example, a plurality of protocols may be pre-established via the user interface, wherein such protocols are each directed to different patient treatment applications and/or protocol preferences of medical personnel.

The protocol data for a given phase may comprise a target patient temperature. Alternatively or additionally, the protocol data for a given phase may comprise a set duration. In one arrangement, the user interface may be adapted to receive user input to establish the protocol data.

For each given protocol, the programmable control module may be adapted to provide output control signals to a thermal exchanger. In turn, the thermal exchanger may be provided to responsively change the temperature of a thermal exchange medium to achieve a desired thermal exchange with a patient. By way of example, the thermal exchange medium may comprise a fluid (e.g. a circulated liquid and/or gas), wherein componentry of the thermal exchanger operates to change the temperature of the thermal exchange medium in corresponding relation to control signals output from the programmable control module.

The patient temperature control system may also include a temperature sensor to sense the temperature of a patient on an ongoing basis and provide a corresponding output signal to the programmable control module. In turn, the programmable control module may utilize the patient temperature measurement signal and target patient temperature protocol data to generate control signals (e.g. on a single phase or phase specific basis). Further, the programmable control module may further employ phase duration protocol data in conjunction with the generation of control signals (e.g. on a single phase or phase specific basis).

The user interface and programmable control module may also be adapted to allow for selective user modification of target patient temperature data and/or phase duration data (e.g. on a single phase or phase specific basis). In turn, a modified protocol may be employed by the programmable control module during any remaining portion of a modified phase.

The user interface may be further adapted with various numerical and graphic user interface functionalities. For example, a graphic display may be provided to visually present plots of target patient temperature adjustment rates for one or more patient treatment phases, together with a plot(s) of a measured patient temperature and/or of a measured temperature of a thermal exchange medium. As may be appreciated, such visual display facilitates medical personnel monitoring of a given patient therapy procedure so as to enhance overall control and responsive action as necessary.

In conjunction with the present invention, an inventive method is also provided for controlling a temperature of a thermal exchange medium in a thermal patient temperature control system. Correspondingly, the method provides for patient temperature control.

The inventive method may comprise a step of establishing a programmed protocol for at least one phase of patient thermal therapy. The method may further include a step of controlling automatically the temperature of a thermal exchange medium of a patient temperature control system, based at least in apart on the programmed protocol, for at least a portion of each of the at least one phase.

In one aspect, the programmed protocol may be established to comprise a target patient temperature and/or a set duration for a plurality of phases of patient thermal therapy. Such phases may be successive or may have one or more therapy phases therebetween.

In another aspect, the establishing step may be repeated a plurality of times so as to result in a plurality of programmed protocols. In turn, the method may include a step of selecting (e.g. by a user at a user interface) one of the plurality of programmed protocols for application in the controlling step.

The controlling step may entail setting the temperature of the thermal exchange medium based at least in part upon a measured patient temperature and a corresponding target patient temperature for a given phase. By way of example, the temperature of the thermal exchange medium may be set (e.g. cooled, maintained or heated) pursuant to a comparison of the measured patient temperature and the corresponding target patient temperature.

In another aspect, a programmed protocol may be established for at least two successive phases of patient treatment. In turn, the controlling step may further provide for the automatic termination and initiation, respectively, of first and second ones of the at least two successive phases in response to a comparison of a measured patient temperature and a target patient temperature for the first one of the two successive phases. In another approach, automatic termination and initiation, respectively, of successive phases may occur upon the expiration of a set phase duration comprising the programmed protocol.

In various applications, the programmed protocol may be established to comprise different target patient temperatures for at least a first set of two of the plurality of phases. Additionally, the programmed protocol may be established to comprise the same target patient temperature for at least a second set of two of the plurality of phases. In one embodiment, the plurality of phases may include at least three successive phases, wherein the target patient temperatures for the three phases are established so as to affect a desired degree of patient cooling/heating during a first phase, maintain the patient at a cooled/heated temperature during a second phase, and heat/cool a patient at desired rate during a third phase of treatment.

Numerous additional aspects and advantages will be apparent to those skilled in the art upon consideration of the further description of embodiments hereinbelow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates one embodiment of a patient temperature control system comprising the present invention.

FIG. 2 illustrates one embodiment of a method for controlling the temperature of a patient via control of the temperature of a thermal exchange medium included in a temperature control system.

FIGS. 3A-3I illustrate exemplary screens of one embodiment of a user interface employable in the system embodiment of FIG. 1 and method embodiment of FIG. 2.

FIGS. 4A-4D illustrate exemplary screens of another embodiment of a user interface employable in the system embodiment of FIG. 1 and method embodiment of FIG. 2.

DETAILED DESCRIPTION

FIG. 1 illustrates one embodiment of a patient temperature control system 1 comprising the present invention. The patient temperature control system 1 may be computer-based to include a user interface 10 for receiving user control input and for providing corresponding signals 12 to a programmable control module 20. User interface 10 may be further adapted to receive signals 14 from the programmable control module 20 for use in the display of control and measured data and for operative, interactive interface with a user at user interface 10. In the later regard, user interface 10 may include an interactive display as further described hereinbelow.

The programmable control module 20 may be provided to store data and generate signals in corresponding relation to a plurality of different patient temperature control phases. Additionally or alternatively, the programmable control module 20 may be provided to facilitate the establishment of one or more programmed protocols that each comprise parameter data for use in the control of each of the plurality of patient temperature control phases. By way of example, the protocol may comprise target patient temperature data for each of a plurality of treatment phases. Further, for one or more of the phases, the protocol may comprise a set duration for thermal treatment.

For each given protocol the programmable control module 20 may provide output control signals 16 to a thermal exchanger 30 on a phase-specific basis. In turn, thermal exchanger 30 may be provided to responsively change the temperature of a thermal exchange medium 40 to affect a desired thermal exchange, e.g. to cool, maintain the temperature of, or heat a patient. For example, thermal exchange medium 40 may comprise a fluid (e.g. a liquid and/or gas), and thermal exchanger 30 may comprise heating and/or cooling componentry which operate to change the temperature of the thermal exchange medium 40 in corresponding relation to control signals 16 output from the programmable control module 20.

In one approach, the programmable control module 20 may be provided for cooling/heating and circulating water as a thermal exchange medium 40 through one or a plurality of fluidly interconnected pads designed for intimate contact with and thermal energy exchange with a patient P, as taught in one or more U.S. Pat. No. 6,669,715 to Hoglund et al.; U.S. Pat. No. 6,827,728 to Ellingboe et al.; U.S. Pat. No. 6,375,674 to Carson; and U.S. Pat. No. 6,645,232 to Carson, all of which are here by incorporated by reference in their entirety.

As illustrated in FIG. 1, the patient temperature control system 1 may further comprise a temperature sensor 50 for measuring the temperature of the thermal exchange medium 40 on an ongoing basis and providing a corresponding output signal 52 to the programmable control module 20. Further, a temperature sensor 60 may be provided to measure the temperature of a patient P on an ongoing basis and provide a corresponding output signal to the programmable control module 20. The temperature sensor 60 may comprise a sensor to measure a core body temperature of the patient P. The output signals 52 and 62 may be employed by the programmable control module 20, together with protocol data and preset algorithms, to generate (e.g. via a processor and/or logic circuit) the control signals 16 provided to thermal exchange 30, so as to yield the desired temperature of thermal exchange medium 40 (e.g. on a single phase or phase specific basis).

FIG. 2 illustrates one embodiment of a method 100 for controlling the temperature of a patient via control of the temperature of a thermal exchange medium included in a multi-phase temperature control system. As illustrated, the method 100 may include an initial step 102 of establishing a protocol that includes target patient temperatures for a plurality of phases (e.g. 2 or more phases having different patient temperature exchange objectives). Such phases may be successive in time and/or spaced in time. The establishment of a protocol may be achieved via use of the programmable control module 20 and operatively interconnected user interface 10 of FIG. 1.

By way of example, the protocol may be established to include target patient temperatures for at least three phases. Such an approach facilitates a procedure in which a patient is cooled/heated to a first target patient temperature in a first phase of therapy, maintained at or within a predetermined range of a second target patient temperature during a second phase (e.g. equal or different than the first target temperature), and heated/cooled to a third target patient temperature during a third phase. In other embodiments, following a third phase of therapy it may be desirable to establish a fourth target patient temperature for use in temperature control during a fourth phase of therapy.

The method may further include a step 104 of controlling the temperature of a thermal exchange medium of a patient temperature control system based on the protocol for each of the plurality of phases, e.g. via control of the thermal exchange 30 to control the temperature of the thermal exchange medium 40 of FIG. 1. In this regard, the protocol may be further established at step 106 so as to include a set duration for one or more of the phases, e.g. via use of a programmable control module 20 and user interface 10 of FIG. 1. In turn, the controlling step 104 may be carried out during such phase(s) for a duration(s) that correspond with the set duration.

In one approach, the controlling step 104 may be carried out in step 108 for each phase by setting the temperature of the thermal exchange medium based upon a measured patient temperature and the target patient temperature for such phase, e.g. via use of a signal from temperature sensor 50 by the programmable control module 20 of FIG. 1. By way of example, the patient temperature may be measured on an ongoing basis during a given phase and compared to the corresponding target patient temperature for such phase. Based upon such comparison, a patient temperature control system may provide for cooling and/or heating of a thermal exchange medium according to any of a plurality of pre-set algorithms, e.g. via control of the heat exchanger 30 by the programmable multi-phase control module 20 of FIG. 1.

In one approach, a control algorithm may provide for simply turning on/off a cooling/heating component of a temperature control system in intervals that depend upon a degree of difference reflected by comparison of the measured patient temperature and target patient temperature. In another approach, a control algorithm may provide for controlling an output magnitude of a cooling/heating component of a temperature control system based upon a degree of difference reflected by comparison of the measured patient temperature and target patient temperature. In another approach, the controlling step 104 may be completed as step 110 for a given phase by setting the temperature of a thermal exchange medium based upon a measured patient temperature, a target patient temperature for such phase, and a set duration for such phase. For example, utilization of the noted parameters accommodates the determination and control use of a target patient temperature adjustment rate for the phase, wherein gradual patient cooling/warming over a desired time period may be facilitated.

In yet another approach, a measured thermal exchange medium temperature may be employed together with a measured patient temperature and target patient temperature to control the heating/cooling of a thermal exchange medium. Such an approach may yield enhanced system response.

The illustrated method 100 may further provide for modification of a given protocol based on user input at step 112, e.g. user input at the user interface 10 of FIG. 1. In this regard, a modified protocol may be employed for the remaining duration of a modified phase(s) and any for phase(s) that have not yet been initiated.

In the illustrated method, a given phase may be automatically terminated at step 114 by expiration of a corresponding set duration included within the programmed protocol for such phase. In this regard, the termination of a given phase may generally correspond with a change in the mode (e.g. cooling or heating) or a change in the magnitude of thermal exchange between a thermal exchange medium and a patient.

Method 100 may also provide for the termination and initiation of successive phases at step 116 in response to a comparison of a measured patient temperature and a target patient temperature. That is, upon determining that a target patient temperature has been reached during a given phase (e.g. via comparison of a measured patient temperature and a target patient temperature for an initial phase of treatment), such phase may be automatically terminated and a successive phase automatically initiated. Alternatively and/or additionally, the method 100 may also provide for the termination and initiation of successive phases in response to the expiration of a set duration for a first one of the two successive phases. The automatic phase termination/initiation features may be selectively established by a user for a given protocol on a phase-specific basis.

FIGS. 3A-3I illustrate an embodiment of an interactive user interface 200 operatively interconnected to a programmable multi-phase control module (e.g., module 20 of FIG. 1) for providing phase-related control and alarm data, and measured data, to a user and for prompting and receiving user control input via interactive screen displays. This embodiment contemplates one implementation of the present invention for patient cooling, e.g. for use in treating stroke, cardiac arrest and/or traumatic brain injury. Such embodiment is described for purposes of illustration and it should be understood that additional embodiments directed to patient cooling for other conditions (e.g. high fever) and/or patient warming may utilize features analogous to those described herein.

With particular reference to the interactive screen 202 of user interface 200 illustrated in FIG. 3A, a plurality of pre-established protocols options may be presented to a user, wherein any one of the protocol options may be selected for use in a given therapy. By way of example, each of the protocol options may be identified (e.g. by a given name) in corresponding spatial relation to an input selection button, wherein a user may select a given one of a plurality of protocol option buttons 220 a, 220 b, 220 c, 220 d or 220 e, e.g. via touch-screen and/or point-and-click functionality.

With reference to FIG. 3B, an interface screen 204 of user interface 200 is illustrated that presents data comprising a pre-established control protocol corresponding with the protocol option button 220 a of FIG. 3A (i.e. entitled “Dr. Jones SCA”). Such protocol includes phase-specific target patient temperature and duration data sets that are presented numerically in a first portion 210 of the user interface 200 and that are presented graphically in a second portion 212 of user interface 200, as will be further described. Prior to the initiation of a given phase, the corresponding phase duration presented in the first portion 210 of user interface 200 may be the value established in the corresponding protocol. After initiation of a given phase, the phase duration presented in the first portion 210 of the interface 200 may be the remaining amount of time, or remaining phase duration, for the given phase.

Each phase-based set of target patient temperature and phase duration data may be selectively modified by a user via interactive buttons 232 and 234 presented in an interactive region 230 of the first portion 210 of user interface 200, e.g. via touch-screen and/or point-and-click functionality. For example, a given data set may be selected and presented in buttons 232 and 234 via user control of interactive buttons 254 and 256, labeled “Next” and “Prev.”, respectively, wherein data sets may be scrolled across the first portion 210, i.e. from interactive region 230 to a non-interactive region 242 or non-interactive region 244 (See FIG. 3C). In turn, for a given data set located in active region 230, button 232 may be selected to modify a corresponding target patient temperature and/or button 234 may be selected to modify a corresponding given phase duration, as will be further described.

Interactive region 230 of user interface of 200 may also include an interactive button 236, entitled “Start” and symbolically displayed with arrows in green, for use in starting/restarting a given phase of therapy, e.g. via touch screen and/or point-and-click functionality. Relatedly, user interface 200 may also include an interactive button 238, labeled “Stop” and symbolically displayed in a red octagon, for using in stopping a given phase of therapy. Additionally, in the illustrated embodiment interface buttons 239 a and 239 b may be provided for user control over specific interconnected thermal exchange system features, e.g. filling of a reservoir with a liquid heat exchange medium that is circulated through pads contacted with a patient for thermal exchange during system operation, and emptying of the liquid thermal exchange medium from such pads (e.g. into the reservoir upon completion of a given patient therapy).

With particular reference to FIG. 3B, a patient target temperature for “Phase 1”, i.e. “33.0° C.”, is presented in corresponding spatial relation to user interface button 232. Further, a patient target temperature for “Phase 2”, i.e. “33.0° C.”, is presented in a non-interactive region 242.

FIG. 3C illustrates an interface screen 206 corresponding with exemplary Phase 2 operations, and FIG. 3D illustrates an interface screen 208 corresponding with exemplary Phase 3 operations. In this regard, interface screen 206 presents a target patient temperature of “33.0° C.” for Phase 2 in interactive region 230, and a target patient temperature of “33.0” and “36.5” for “Phase 1” and “Phase 3”, respectively, in non-interactive regions 244 and 242, respectively. Similarly, interface screen 208 presents a target patient temperature of “36.5° C.” for Phase 3 in interactive region 230, and a target patient temperature of “33.0” for Phase 2 in non-interactive region 244.

Screens 204, 206 and 208 of FIG. 3B, FIG. 3C and FIG. 3D also provide protocol data regarding corresponding set phase durations, or remaining durations, of Phases 1-3. More particularly, in relation to “Phase 2” and “Phase 3”, the corresponding set durations of “11:00” and “04:30” are presented in the non-interactive informational region 242 of FIGS. 3B and 3C, respectively. In FIG. 3C the remaining duration of “Phase 2” is illustrated as “6:05 Hr.”, since a portion of Phase 2 has already passed (i.e. 4 hours and 55 minutes). Similarly, in FIG. 3D the remaining duration of “Phase 3” is illustrated as “00:50 Hr.”, since a portion of Phase 3 has already passed (i.e. 3 hours and 40 minutes).

With respect to FIG. 3B the corresponding phase duration for Phase 1 is a minimum amount of time entailed to lower the temperature of a given patient to the target patient temperature for “Phase 1”, i.e. 33.0° C., with the system operating at pre-set maximum rate. As such, the duration information corresponding with “Phase “1 is presented in duration button 236 as “Rapid”.

As noted above, phase-specific target patient temperature and phase duration data sets may be presented graphically in a second portion 212 of user interface 200, as reflected by FIG. 3B, FIG. 3C and FIG. 3D. In this regard, the phase-specific target patient temperature and phase duration data may be utilized to generate a plot of a target patient temperature level as a function of time-in-therapy. This may be characterized as a target patient temperature adjustment rate. For example, and as shown in FIG. 3B, FIG. 3C, and FIG. 3D a temperature-to-time graphic display region 214 may illustrate a target patient temperature plot 260 (e.g. a dashed line), wherein an interactive button 216 may be utilized to control the units of temperature display, i.e. ° C. or ° F.

In relation to the target patient temperature plot 260, a first target patient temperature for Phase 1 corresponds with the location of a first plot point 260 a, a second target patient temperature and a corresponding phase duration for Phase 2 correspond with the location of a second plot point 260 b, a third target patient temperature and corresponding phase duration for Phase 3 correspond with the location of a third plot point 260 c, and a fourth target patient temperature for a final phase corresponds with the location of a fourth plot point 260 d. In relation to Phase 1, the target patient temperature plot portion, or slope, may be generated based upon a starting, measured patient temperature, the Phase 1 target patient temperature, and a predicted rate of cooling for Phase 1 operations based upon known system cooling parameters. In short, the plot position for Phase 1 reflects a predicted patient temperature adjustment rate.

As illustrated in FIG. 3B, FIG. 3C and FIG. 3D, user interface 200 may also be provided to numerically display a measured patient temperature on an ongoing basis in the second portion 212. Similarly, user interface 200 may be provided to numerically present a measured water temperature (e.g. as employed as a thermal exchange medium) on an ongoing basis.

In this regard, user interface 200 may be adapted to graphically present, or plot, the measured patient and water temperatures on an ongoing basis in the graphic display region 214. By way of example, FIG. 3C and FIG. 3D illustrate a measured patient temperature plot 252 (e.g. a relatively thin line) and a measured water temperature plot 262 (e.g. a relatively thick line), both in time-based relation to the target patient temperature plot 260. Further, the graphic display region 214 may be selectively expanded via user interface with a button 218 entitled “EXPAND GRAPH”, wherein the plots 252, 260 and 262 may be displayed in relation to an expanded graph. Additionally, the graphic display region 214 may be provided to visually indicate which of a plurality of therapy phases is currently in process. For example, in FIG. 3B a portion of the graphic display region 214 may be presented in a different manner (e.g. a different color) than the rest of the display (e.g. as indicated by angled lines in FIG. 3B) to indicate that “Phase 1” has been or is about to be initiated. Similarly, in FIG. 3C a portion of graphic display region 214 visually indicates that “Phase 2” is currently-in-process (e.g. via a different color than the rest of the display as reflected by the diagonal lines of FIG. 3C), and in FIG. 3D graphic display region 214 visually indicates that “Phase 3” is underway.

Of note, the measured patient temperature plot 252 and target patient temperature plot 260 may each be graphically presented in corresponding unit relation to a first temperature scale, i.e. “PATIENT TEMP ° C.” as provided along the left side of the graphic display region 214. Such corresponding unit relationship may be further visually highlighted for a user by presenting the “PATIENT TEMP ° C.” indicator and temperature unit measures, e.g. “30” to “40” in FIG. 3C in a color (e.g. yellow) or other unique manner that corresponds with the color (e.g. yellow) or other unique manner of display for the measured patient temperature plot 252 and target patient temperature plot 260.

Further, the measured water temperature plot 262 may be graphically presented in corresponding unit relation to a second temperature scale, i.e. “WATER TEMP ° C.”, as provided along the right side of the graphic display region 214. Such corresponding unit relationship may be further visually highlighted for a user by presenting the “WATER TEMP ° C.” indicator and temperature unit measures, e.g. “4” to “44” in FIG. 3C, in a color (e.g. blue) or other unique manner that corresponds with the color (e.g. blue) or other unique manner of display for the measured water temperature plot 262, and that is otherwise different from the color (e.g. yellow) or manner of display for the measured patient temperature plot 252, target patient temperature plot 262 and their corresponding unit indicators.

Of further note, it may be noted that the scaling of the above-noted unit temperature measures along the left side and right side of the graphic display region 214 may be different. Such difference in scaling accommodates differences between the measured/target patient-related temperature indicator and the measured water-related temperature indicators. For example, in relation to FIG. 3C, the measured/target patient related-temperature indicator range is from 30° C. to 40° C., while the measured water related-temperature indicator range is from 4° C. to 44° C. By accommodating such range differences, the measured and target patient-related temperature plots may more noticeably reflect smaller degrees of temperature change. More generally, and as may be appreciated, many of the other display capabilities described above facilitate user visual monitoring and attendant responsive control of a patient therapy session.

In this regard, and as previously noted, the phase-specific target patient temperature and phase duration data of a given protocol may be modified in a given case utilizing buttons 232 and 234, respectively. For example, when button 232 illustrated in FIG. 3B is selected by a user, a screen 210 may be displayed as shown in FIG. 3E. In turn, magnitude control buttons 270 a, 270 b may be utilized to change the target patient temperature for Phase 2 to a desired magnitude, and then applied or cancelled via selection of button 272 a entitled “OK” or button 272 b entitled “Cancel”.

Similarly, when button 234 illustrated in FIG. 3B is selected by user, a screen 212 may be displayed as shown in FIG. 3F. In turn, magnitude control button 274 a, 274 b may be utilize to change the phase duration of Phase 2 and then applied or cancelled via selection of button 276 a entitled “OK” or button 276 b entitled “Cancel”. Upon modification of target patient temperature protocol data or a phase duration protocol data by a user, the interconnected programmable multi-phase control module will control the cooling/heating of the thermal exchange medium in accordance with the modified protocol data. Correspondingly, the user interface 200 may be adapted so that the target patient temperature plot 260 on the graphic display 214 will automatically reflect such changes.

Returning now to FIG. 3A, interactive screen 202 includes an interactive button 222 entitled “Advanced Set-Up” for use in establishing one or more protocols. In particular, upon user selection of the interactive button 222, an interactive screen 290 may be presented as illustrated in FIG. 3G. In turn, upon user selection of a given menu list item by a user (e.g. via touch screen or point-and-click functionality), further corresponding screens may be presented. For example, upon selection of the menu item “Set-Up Protocols”, a user may access a plurality of screens to establish a name of a protocol, and corresponding control data and alarm condition data on a phase-specific basis.

In this regard, control functionality may be included in various embodiments that provides for the establishment of a protocol to facilitate phase-specific patient therapy in one of either a manual mode or an automatic mode of operation for each given phase of patient treatment. In one embodiment, subsequent to selection of the “Set-Up Protocols” menu item of screen 290 of FIG. 3G, a user may proceed to establish control and alarm condition data for a given phase (e.g. Phase 1, Phase 2 etc.) wherein a pop-up window may be presented (not shown) that allows a user to select one of either an “Automatic” mode or a “Manual” mode of operation for the given phase.

By way of example, upon selection of a “Manual” mode option for Phase 1 operation, a screen 292 may be presented as shown in FIG. 3H. More particularly, interactive screen 292 may be provided to receive user input parameters in a plurality of fields 280 a, corresponding with a plurality of data types indicated by corresponding data field names 282 a. In the later regard, the data field names 282 a, may be displayed in a manner that prompt a user to input corresponding data into fields 280 a, (e.g., by blinking and/or being displayed in a preset color until the data is entered).

In the illustrated embodiment of FIG. 3H, two optional pre-set conditions may be set by a user in relation to Phasel-Manual mode operations. First, a user may establish a first condition, e.g. via selection of a “Y” option as opposed to a “N” option, to automatically switch from Phase 1—Manual mode operation to a next phase of operation, e.g. Phase 2, upon the expiration of a set duration of Manual mode operation. In the illustrated embodiment, such “Duration” has been inputted as protocol data by a user to be “1:00 Hr.”. As further illustrated, a second condition may be selected by a user, e.g. the selection of “Y” as opposed to a “N” option, to automatically switch from the Phase 1-Manual mode of operation to a next phase of operation, e.g. Phase 2, upon system receipt and processing of a measured patient temperature signal that indicates that a patient has “stabilized” in terms of physiological temperature response.

As further reflected by FIG. 3H, a user may input control data establishing a target temperature for a thermal exchange medium, e.g. a water target temperature, wherein during the Manual mode a patient temperature control system will cool/heat the thermal exchange medium at a predetermined maximum rate to reach the set thermal exchange medium temperature (e.g. “4.0 C” for the “Water target”), and will continue to operate at the set temperature until the mode is terminated. Upon user selection of an “Automatic” mode option for Phase 1 operation, a user a screen 294 may be presented as shown in FIG. 3I. More particularly, interactive screen 294 may be provided to receive user input parameters in a plurality of fields 280 b, corresponding with a plurality of data types indicated by corresponding data field names 282 b. In the later regard, the data field names 282 b may be displayed in a manner that prompt a user to input corresponding data into fields 280 b (e.g., by blinking and/or being displayed in a preset color until the data is entered).

By way of example, the input parameters may include protocol control data to set a patient target temperature, e.g. the patient target temperature of Phase 1 in the displayed embodiment has been set by a user at “33.0 C”, and a set phase “Duration”. Further, the user interface 200 may provide for user input regarding automatic termination of Phase 1-Automatic mode and initiation of Phase 2 operations upon one of two alternate pre-set condition(s) being met. First, a user may establish a first pre-condition (e.g., via selection of a “T” option), to automatically “jump” from Phase 1-Automatic mode operation to Phase 2 operation when a measured patient temperature reaches the protocol patient target temperature for Phase 1, i.e., “37.0 C”. Alternatively, a user may establish a second pre-condition, e.g., via selection of a “D” option, to jump from Phase 1-Automatic mode operation to Phase 2 operation upon the expiration of the protocol set duration of Phase 1. In the illustrated embodiment, such set duration has been inputted by the user to be “6:00 Hr”. Alternatively, a user may establish, e.g. via selection of a “N” option, that automatic jumping is not desired.

As further reflected by FIGS. 3H and 3I, user interface 200 may be further provided to allow for user input to establish phase-specific, e.g. phase-mode-specific, alarm condition data. In particular, in relation to the Phase 1—Manual mode of operation, a patient high temperature alert level, e.g., “40.0 C”, and a patient low temperature alert level, e.g., “33.0 C” may be set. Similarly, in relation to the Phase 1-Automatic mode of operation, a patient high temperature alert level, e.g. “40.0 C”, and a patient low temperature alert level, e.g. “33.0 C” may be set. In turn, during a given mode when a measured patient temperature signal goes outside of the corresponding high/low range of patient temperature, user interface 200 may be adapted to provide an alert output to a user. For example, a pop-up window and/or audible output alert may be provided to a user that not only alerts the user to the presence of an alarm condition, but also informs the user as to the particular condition and identifies potential remedial user response options. Such functionality may be extended to thermal exchange medium temperature limits, e.g. water high temperature and water low temperature, alarm condition alert levels for application in Phase 1-Automatic mode operations, as indicated in FIG. 3H.

In addition to Phase 1 protocol control and alarm condition data, it should be appreciated that the user interface 200 may provide additional screens similar to screens 292 and 294 that provide for the entry of protocol control data and alarm condition data for one or more additional phases of operation. In this regard, a user may pre-establish data for multiple phases, as may be desired by a given practitioner.

FIGS. 4A-4D illustrate selected aspects of another embodiment of an interactive user interface 300 operatively interconnected to a programmable control module (e.g. module 20 of FIG. 1) for providing phase-related control and alarm data, and measured data, to a user and for interfacing with a user to receive control input via various interactive screen displays. This embodiment contemplates an implementation of the present invention directed to two alternative patient therapy protocols, i.e. for normothermia therapy and for hypothermia therapy (e.g. for use in treating stroke, cardiac arrest and/or traumatic brain injury). Again, such embodiments are described for purposes of illustration and additional embodiments will be apparent to those skilled in the art.

With particular reference to the interactive screen 302 of user interface 300 illustrated in FIG. 4A, two alternate protocol options may be presented to a user for use in a given therapy procedure. As shown, the two alternate options are entitled “NORMOTHERMIA CASE” and “HYPOTHERMIA CASE”, wherein a user may select a given one of the two options utilizing buttons 320 a or 320 b, e.g. via touch-screen and/or point-and-click functionality.

With reference to FIG. 4B, an interface screen 304 of user interface 300 is illustrated that presents data comprising a pre-established control protocol corresponding with the protocol option button 320 b of FIG. 4A (i.e. entitled “HYPOTHERMIA CASE”). Such protocol includes two phase-specific target patient temperature and duration data sets that are presented numerically in interactive display regions 330 and 342 of user interface 300.

Each phase-based set of target patient temperature and phase duration data may be selectively modified by a user via interactive buttons 332 a and 332 b, as presented in the interactive regions 330 and 342, via touch-screen and/or point and click functionality. More particularly, a given data set may be adjusted utilizing button 332 a or 332 b entitled “ADJUST”, and immediately applied utilizing button 334 a or 334 b entitled “START”. In the former regard, for example, for the cooling phase corresponding with interactive region 330, the corresponding target patient temperature and phase duration data may be adjusted via user interface with button 332 a to access pop-up window 370 shown in FIG. 4C. In turn, control buttons 372 may be utilized to adjust the parameters and control button 374 entitled “SAVE” may be employed to save the adjusted parameters.

With further reference to FIG. 4B, phase-specific target patient temperature and phase duration data may be utilized to generate a target patient temperature adjustment rate plot 360 that is presented graphically in a graphic display region 312 of the user interface 300. As may be appreciated, measured patient temperature data and measured water temperature data may also be numerically displayed and utilized to generate corresponding plots for display in the graphic display region 312, in a manner analogous to that described in relation to the embodiment of FIGS. 3A-3I addressed above. Further, the graphic display region 312 may visually highlight a phase that is currently in process, e.g. via color differentiation for such phase in corresponding relation to a color utilized in the phase-oriented interaction regions 330 and 342.

Reference is again made to FIG. 4A, wherein interactive screen 302 includes an interactive button 322 entitled “ADVANCED SET-UP” for use in establishing the two optimal protocols. In particular, upon selection of the interactive button 322, an interactive screen 390 may be presented as illustrated in FIG. 4D. In turn, the various interactive control buttons presented on screen 394 may be utilized to establish parameters and protocol control data in a manner analogous to that described above in relation to FIGS. 3G, 3H and 3I. In this regard, such user control may be facilitated via the consistent intuitive use of an “ADJUST” button to access pop-up windows that are easy to employ, as per the pop-up window shown in FIG. 4C above.

The various embodiments described above are for purposes of illustration and are not intended to limit to scope of the present invention. 

1.-36. (canceled)
 37. A method for use in a patient temperature control system, comprising: storing a programmed protocol at a programmable control module in response to user input at a user interface, the programmed protocol comprising a plurality of phases that are successive and non-overlapping in time, wherein target patient temperature data and phase duration data are stored for each of the corresponding plurality of phases; controlling automatically by the programmable control module a temperature of a thermal exchange medium of the patient temperature control system based at least in part upon the programmed protocol; providing a user interface screen in communication with the programmable control module for presenting data corresponding with the programmed protocol including: presenting numerical phase-based information in a first portion of the interface screen, wherein the numerical phase-based information includes a phase-based target patient temperature and phase duration data set for each of the plurality of phases of the programmed protocol; receiving at the programmable control module a sensor output signal of a measured patient temperature on an ongoing basis and a measured temperature of the thermal exchange medium on an ongoing basis; wherein an interactive region of the first portion of the interface screen is provided for: receiving user input to establish and to modify each phase-based target patient temperature and phase duration data set for each given phase of the plurality of phases of the programmed protocol; and, receiving user input to establish patient temperature alarm condition data for each of the plurality of phases of the programmed protocol and measured thermal exchange medium temperature alarm condition data for each of the plurality of phases of the programmed protocol.
 38. A method as recited in claim 37, wherein the user interface screen is provided for: receiving user input patient temperature alarm condition data comprising a patient high temperature alert level and a patient low temperature alert level for each of the plurality of phases of the programmed protocol; and, wherein the user interface is adapted to provide an alert output when the measured patient temperature is above the patient high temperature alert level or below the patient low temperature alert level for a given phase of the plurality of phases of the programmed protocol.
 39. A method as recited in claim 38, wherein said alert output informs a user as to the particular alarm condition.
 40. A method as recited in claim 39, wherein said alert output identifies a potential remedial user response option.
 41. A method as recited in claim 38, wherein said user alert comprises at least one of a pop-up window and an audible output.
 42. A method as recited in claim 38, wherein the user interface screen is provided for: receiving user input thermal exchange medium temperature alarm condition data comprising a thermal exchange medium high temperature alert level and a thermal exchange medium low temperature alert level for each of the plurality of phases of the programmed protocol; and, wherein the user interface is adapted to provide an alert output when the measured thermal exchange medium temperature is above the thermal exchange medium high temperature alert level or below the thermal exchange medium low temperature alert level for a given phase of the plurality of phases of the programmed protocol.
 43. A method as recited in claim 42, wherein said alert output informs a user as to the particular alarm condition.
 44. A method as recited in claim 43, wherein said alert output identifies a potential remedial user response option.
 45. A method as recited in claim 42, wherein said user alert comprises at least one of a pop-up window and an audible output.
 46. A method as recited in claim 37, wherein for each given phase-based target patient temperature and phase duration data set for each given phase of the plurality of phases said presenting includes: presenting, prior to the initiation of the given phase, an indication of the corresponding phase duration; and, presenting, after the initiation of the given phase, an indication of the remaining amount of time of the corresponding phase duration.
 47. A method as recited in claim 37, wherein said user interface screen is provided for user control to present a single given phase-based target patient temperature and phase duration data set for each given phase of the plurality of phases of the programmed protocol in said interactive region.
 48. A method as recited in claim 37, wherein said interactive region is provided for user control to start a given phase of the plurality of phases of the programmed protocol corresponding with the single given phase-based target patient temperature and phase duration data set presented in the interactive region.
 49. A method as recited in claim 48, wherein the interface screen is further provided for user control to stop the given phase of the plurality of phases of the programmed protocol.
 50. A method as recited in claim 37, wherein the interface screen is further provided for user control of filling of a reservoir of a patient temperature control system with said thermal exchange medium for circulation through one or more pads contacted with a patient for thermal exchange, and for emptying the thermal exchange medium from said one or more pads into the reservoir.
 51. A method as recited in claim 37, wherein upon user modification of either or both of the target patient temperature data or the phase duration data of a given phase-based data set for a given phase of the plurality of phases of the programmed protocol, the programmable control module is operable to change said controlling.
 52. A method as recited in claim 51, wherein said providing further comprises: displaying graphical phase-based information in a second portion of the interface screen, wherein the graphical phase-based information includes a graphical plot of target patent temperature as a function of time for each of the plurality of phases corresponding with the programmed protocol, relative to a first temperature scale and a time scale.
 53. A method as recited in claim 52, wherein for each of the plurality of phases of the programmed protocol said displaying includes: utilizing the corresponding phase-based target patient temperature and phase duration data set to generate the graphical plot of target patient temperature as a function of time.
 54. A method as recited in claim 52, further comprising: displaying a graphical plot of the measured temperature of the thermal exchange medium as a function of time in the second screen portion of the interface screen, relative to a second temperature scale and said time scale.
 55. A method as recited in claim 54, wherein said user interface screen is provided to numerically display said measured patient temperature and said measured temperature of the thermal exchange medium on an ongoing basis in said second portion of the interface screen.
 56. A method as recited in claim 55, wherein said user interface screen is provided to numerically display a total remaining time for completion of all of the plurality of phases corresponding with the programmed protocol. 